A Safety Study of Mebendazole in Children 2 to 10 Years of Age

Conditions: Soil-transmitted helminth (STH) infections
MedDRA version: 17.1Level: LLTClassification code 10063126Term: WormsSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

Registration Number: EUCTR2015-001226-42-Outside-EU/EEA

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 397

Inclusion Criteria

- Be an otherwise healthy child based on medical history, physical examination, vital signs, and concomitant medications and live in a high-prevalence area where parasite infection is endemic (ie, Prevalent in or peculiar to a particular locality, region, or people)
- Have teeth and be able to chew the mebendazole chewable tablet
- Girls must be premenarchal
- Parent(s)/guardians of study participants (or their legally-accepted representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study

Are the trial subjects under 18? yes
Number of subjects for this age range: 397
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Have a history of clinically significant liver or renal insufficiency
- cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (eg, anemia), rheumatologic, psychiatric, or metabolic disturbances that, in the opinion of the investigator, renders the candidate not suitable for mebendazole treatment
- Have a suspected massive intestinal parasitic infection, based on history and physical findings, as determined by the principal investigator
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the study participant or the study or prevent the study participant from meeting or performing study requirements

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study was to assess the safety and tolerability of a mebendazole 500-mg chewable tablet formulation in a pediatric population (children 2 to 10 years of age, inclusive).;Secondary Objective: Not applicable;Primary end point(s): The number, severity, relationship to study drug, and type of adverse events reported.;Timepoint(s) of evaluation of this end point: Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change in physical examination<br>- Change in vital sign measurements;Timepoint(s) of evaluation of this end point: Baseline (Day 1) to the end of study (Day 3) or early withdrawal visit